There has been a major crack down on illegal pharmacies over the past year. But how many convictions have actually been made and is it as big a concern as it was a year ago?
The Clinton Administration brought the issue to the forefront with its initiative in December to invest $10 million to help the FDA "identify, investigate, and prosecute Web sites selling such items as: prescription drugs without a valid prescription, unapproved new drugs, counterfeit drugs, and expired or illegally diverted pharmaceuticals."
John Henkel reported in FDA Consumer Magazine in January that "In July 1999, the FDA announced that it was joining forces with state regulatory agencies and law enforcement groups to combat illegal domestic sales of prescription drugs.
The agency signed agreements with the National Association of Boards of Pharmacy and the Federation of State Medical Boards. These organizations have made a commitment to help enforce federal and state laws against unlawful Internet sellers and prescribers of drugs in the United States."
One activity that the FDA took exception to was the way Viagra prescriptions were being filled by the use of an online questionnaire.
Henkel reported in his article that a 52-year-old Illinois man with episodes of chest pain and a family history of heart disease died of a heart attack last March after buying the impotence drug Viagra from an online drugstore that required only answers to a questionnaire to qualify for a prescription.
Henkel points out "though there is no proof linking the man's death to Viagra, FDA officials say that a traditional doctor-patient relationship, along with a physical examination, may have uncovered any health problems such as heart disease, and could have ensured that proper treatments were prescribed."
This tends to contradict other findings. Research indicates that other men have had heart attacks while on Viagra and these men had been prescribed Viagra through traditional doctor-patient relationships.
In a recent article in Associated Press, Daniel Q. Haney reported the finding of Dr. Sanjay Kaul of Cedars-Sinai Medical Center in Los Angeles who had reviewed Viagra reports sent to the FDA between April 1998 and May 1999.
There were 522 deaths reported. Of that number 200 were heart attacks and 94 were cardiac arrests. There were 79 of the heart attack victims who had been taking nitroglycerin for chest pains.
In Haney's article it was also reported that men with erectile dysfunction also have other medical problems and the chances are they will die of heart attack whether they are taking Viagra or not. In other words studies indicate that impotence is often an indicator of other more serious health problems like cardiovascular disease.
Tom Spring interviewed William A. Stallknecht, R.Ph president of the Internet Pharmacy, the Pill Box, in PC World in June 1999 who said that "there was nothing inherently dangerous about writing a prescription for a patient a doctor has never seen. ...These prescriptions are not illegal. They're bona fide prescriptions with bona fide doctor patient relationships.' Stallknecht said."
At that time Spring had also interviewed Jill Wiggins of the Texas State Board of Medical Examiners, which licenses doctors, who said they had found no reason for disciplinary action against the Pill Box's site, which operated out of San Antonio, Texas.
When contacted recently Stallknecht said he no longer had his online pharmacy. He closed it down when Texas made changes to its policy in December.
In his article Spring had reported Stallknecht as saying that the pharmaceutical drugs he was selling online primarily Viagra, Propecia, Claritin, and Xenical were safe. 'These drugs only require a prescription because "manufacturers are "milking their patents" before they expire and the drugs become available over the counter.'
Claritin for instance can be bought legally over the counter in countries like Canada at a lower cost.
As it is now Americans cannot buy prescription drugs from Canadian pharmacies over the Internet. According to Janet Cooper, B.Sc. (Pharm.) Director, Practice Development of the Canadian Pharmacists Association, there are a few Internet drugstores in Canada but the prescription must come from a licensed prescriber in the province the prescription is being issued.
"The pharmacy must have a written, faxed Rx or take a verbal order directly from the physician.... If a patient has existing refills on a prescription from a pharmacy, they can request a refill on-line." A prescription from an American physician cannot be accepted, unless that physician has a license to practice in Canada as well, she said.
The Canadian Pharmacists Association Website says that "in September 1999, the Provincial Pharmacy Registrars initiated discussions with the U.S. National Association of Boards of Pharmacy (NABP) to possibly adopt or adapt the VIPPS program (Verified Internet Pharmacy Practice Sites) for use in Canada.
Development is underway nationally for either a VIPPS or similar Canadian-made certification program. Development will include external consultation with CPhA and other pharmacy organizations," the site reported.
Whether the VIPPS designation on an International site means that Americans will be able to purchase pharmaceuticals from the foreign site remains to be seen.
As it is now there are organizations in the US who are trying to bring in laws to prevent Americans from buying drugs from foreign companies.
Potential legislation to prevent this from happening has already been presented in the House but did not pass. In July Reuters reported that the House "signaled its concern about high drug prices, voting on two separate amendments to the fiscal 2001 spending bill for the FDA to suspend the agency's enforcement of a 1988 law that bars the re-importation of prescription drugs."
One amendment offered by Rep. Joseph Crowley, D-N.Y., and passed by a vote of 363-12, prevented the FDA from enforcing a law that made it illegal to bring back into the country US made prescription drugs that had been shipped out.
The other amendment, offered by Reps. Tom Coburn, R-Okla., and John Baldacci, D-Maine, which passed 370-12, would prohibit the FDA from acting to interfere with the importation of drugs approved in the US that were made in FDA- approved facilities in the US, Canada or Mexico.
Reuters reported "Supporters of the amendments said that drug companies discriminate against US purchasers by charging them higher prices. "Many American citizens cannot bear what the pharmaceuticals are charging," said Baldacci, who added that Congress should approve the language "to send a message that this is not an acceptable practice."
Congressman Ron Klink (D-PA) and Congressman John Dingell (D-MI) were concerned that the legislation, which makes it easier for U.S. citizens to attain drugs from foreign sources, would increase the likelihood of counterfeit, misbranded, or adulterated drugs entering the United States.
In a press release on Klink's Website they urged the Pharmaceutical Research Manufacturers of America (PHRMA) to address the problem of illegal Internet drug sales. Klink pointed out that "while PHRMA had vociferously opposed the importation legislation they had been disturbingly silent on the issue of on-line drug sales."
It is the high cost of drugs in the US that is driving Americans to find cheaper means of obtaining their medicine.
In June the Public Citizen, New York Statewide Senior Action Council and Citizen Action of New York sponsored a bus trip for seniors so that they could buy prescription drugs at 50% less in Canada.
The seniors went from Albany, Binghamton and Rochester areas to Montreal, Canada, which took them about 30 hours. Once in Canada, they were seen by a doctor who performed an examination and issued them a Canadian prescription.
"Congress needs to intervene to make prescription drugs just as affordable for seniors in New York, and every other state, as they are for Canadian seniors," Mary Clark, southern tier regional director, Citizen Action of New York said in a June press release issued by Public Citizen.
"It is shameful that American citizens are forced to travel to a foreign country to buy prescription drugs at affordable prices," said Michael Burgess, Executive Director, New York Statewide Senior Action Council.
Doug Levy wrote in USA TODAY "in Canada, provincial authorities negotiate bulk discounts with pharmaceutical companies and establish allowable prices for most prescriptions. Pharmacists are required to fill prescriptions with less expensive generics whenever possible. In Mexico, the government sets price ceilings for all medicines."
In July Families USA released a report showing "annual spending on prescription drugs per elderly American will grow from $559 in 1992 to an estimated $1,205 in 2000, an increase of 116 percent. By 2010, annual prescription drug spending per elderly American is projected to increase to $2,810, a jump of 133 percent over this year and more than 403 percent higher than 1992."
In July Charnicia E. Huggins reported in Reuters Health that infertile American couples who wanted to have children but who couldn't afford expensive medical treatments purchased fertility drugs from unlicensed sellers on the Internet.
'"Every day in the US, patients (are) purchasing (fertility medications) from strangers," Pamela Madsen, executive director of the American Infertility Association told Reuters Health. "Even though they're in a desperate, terrible position, (it's an) unsafe practice," she added.... To save money, some individuals elect to purchase medications over the Internet from either foreign drug companies or from strangers who advertise on message boards.'
If Americans are able to purchase pharmaceuticals over the Internet from legitimate online pharmacies in countries like Mexico and Canada, there is no question that it will put a significant dent in US pharmaceutical industry profits.
Are Internet pharmacies getting a bad rap because they could potentially cut into the profits of powerful pharmaceutical companies?
Are online prescribing methods any different from what goes on in traditonal doctor patient relationships in the US?
In July 1999 the AMA reemphasized its recommendations on Internet prescribing practices when Herman I Abromowitz, MD, American Medical Association Trustee told the Oversight and Investigations Subcommittee that,
" A physician should establish or have ready access to a reliable medical history, which generally should include a physical examination of the patient.
The reality however is that with the advent of HMO's (health maintenance organizations) the practice of writing prescriptions without seeing a patient has become common practice in the US. In order for physicians to cut costs, physician's assistants and nurse practioners often see patients who in turn report their findings to the prescribing physician.
Michael Freeny a Longwood psychotherapist wrote in the Orlando Sentinel in August 1999 about HMOs, "....insurers, who ultimately control the purse strings, usually have a prepaid, fixed -dollar budget. Each and every patient visit reduces their profit, taking away money they've already been paid. Insurers basically make money by not providing care.
This issue is played out everyday when doctors and insurers try to determine what is medically necessary for the patient."
HMOs also have the authority to change a prescription that a doctor has written for a patient. CBS channel 2000.com reported one experience involving Marcio Pinheiro, a psychiatrist at Springfield Hospital Center in Sykesville, Md.
His patient's wife went to the pharmacy to pick up her husband's medication, an antidepressant called Wellbutrin but when she got there the pharmacist told her Wellbutrin was no longer on the list of medications approved by her insurance company. Instead, they suggested substituting "similar" medication, such as Zoloft, Paxil, or Serzone.
Pinheiro had apparently already tried one of these medications on the patient but without success. The article further reported, "that's basically what happens when an insurance company forces a pharmacist to replace the medication your doctor prescribed with a lower -cost drug. HMOs often attempt to substitute similar drugs for the ones preferred by doctors in an effort to keep medication costs down."
This type of prescribing is certainly contradictory to recommendations made by the AMA in its position on Internet prescribing practices.
With these types of practices already in existence it seems hypocritical that the FDA would be going after Internet pharmacies for establishing Internet related doctor -patient relationships.
In March Tom McCinnis, director of pharmacy affairs in the FDA's Office of Policy had reported in Bloomberg News that several online pharmaceutical sites were under investigation.
But by May Reuters reported that only two convictions involving online prescription drugs sites had been made.
William Hubbard, a senior associate commissioner at the Food and Drug Administration was reported in the article as having told congress that the investigations had led to 43 arrests and 22 criminal convictions.
Rep. Thomas Bliley, R-Va., responded by saying that "none of the arrests or convictions the FDA cited involved prescription drug sales but were for illegal drugs. A Justice Department official said the department had brought cases resulting in two convictions involving prescription drugs sold online."
These findings indicate that there just aren't as many delinquent online pharmacies as what authorities were first led to believe. Changes in the past year have caused online pharmacies to make changes to comply or to close down.
In an effort to create standards for online drugstores, the National Association of Boards of Pharmacy also developed its Verified Internet Pharmacy Practice Sites designation last year. To be VIPPS certified, a pharmacy must comply with the licensing and inspection requirements of their state and each state to which they dispense pharmaceuticals.
Henkel reported that "VIPPS officials say the program is especially beneficial to seniors. "There is particular concern among the elderly population, which is often the target of unscrupulous marketing ploys," says Kevin Kinkade, NABP executive committee chairman.
"VIPPS will be of tremendous benefit to consumers who need to be certain that the prescription medications they receive are from legitimate online pharmacies."'
But will it? The VIPPS Website reveals that it can cost a company over $8000 to get Internet pharmacy certification. To date there are only seven Internet pharmacies listed as having VIPPS designation.
This designation may inadvertently be a way for the larger pharmaceutical companies to eliminate the smaller competition and drive up the price for online drugs.
It remains to be seen what new laws may come into effect over the next year to monitor the online pharmaceutical situation.
Whatever legislators decide to do they should take a long hard look at existing practices and determine if Internet prescribing is really all that different from what already exists.
As Henkel points out in his article many online pharmacies "are lawful enterprises that genuinely offer convenience, privacy, and the safeguards of traditional procedures for prescribing drugs. For the most part, consumers can use these services with the same confidence they have in their neighborhood druggist. In fact, while some are familiar large drugstore chains, many of these legitimate businesses are local "mom and pop" pharmacies, set up to serve their customers electronically."
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